POS1325 TREATMENT WITH NINTEDANIB IN SYSTEMIC SCLEROSIS ASSOCIATED WITH INTERSTITIAL LUNG DISEASE: SAFETY AND EFFECTIVENESS AFTER ONE YEAR IN A REAL-LIFE COHORT
Authors: J. Corada, A. Guillen-Del-Castillo, I. Blazquez, C. Codina, A. Antón, J. Mestre, A. Gil, J. Perurena-Prieto, I. Ojanguren, A. Villar, C. P. Simeon Aznar
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> Interstitial Lung Disease (ILD) is detected in 80% of the high resolution CT scans (HRCT) of patients with Systemic Sclerosis (SSc). ILD is responsible for 60% of the mortality related to SSc. Although classic treatment is based on immunosuppressant therapies, nintedanib has recently been approved for SSc-ILD as disease modifying antifibrotic drug. <h3>Objectives</h3> To describe the safety and effectiveness of nintedanib over one year follow-up in a cohort of SSc-ILD patients. <h3>Methods</h3> Basal characteristics of SSc patients, concomitant therapy, adverse events, and pulmonary function test after one year of nintedanib treatment were collected in a cohort with SSc-ILD from a tertiary hospital. SPSS 20.0 was used for descriptive statistics. <h3>Results</h3> Twenty-two patients were treated with nintedanib for SSc-ILD, 17 (77.3%) of the patients were women, with a median (interquartilic range, IQR) age at ILD diagnosis of 45.7 (39.4 – 56.8) years, and with a median extent of ILD features in the HRCT at the beginning of the treatment of 29.7% (20.0% - 39.9%). The median period from the ILD diagnosis to nintedanib initiation was 46.5 months. As concomitant therapies, 17 (77.3%) were under mycophenolate acid, 7 (31.8%) received previously intravenous cyclophosphamide, and 8 (36.4%) had taken rituximab previously or during nintedanib treatment. In terms of security profile, 17 out of 22 (81.4%) patients presented some infection –severe infections were described only in 3 cases-, taking into account that among them 14 (82.4%) patients were under concomitant immunosuppressant treatment. Nine (40.9%) patients suffered from diarrhea, and 5 (22.7%) presented elevation of liver enzymes, which required dose reduction in 2 (9.1%), temporary interruption of nintedanib in another 2 (9.1%), and permanent withdrawal in 1 (4.5%) patient. During a median period of follow-up of 29.5 months, 3 (13.6%) patients died, 13 (59.1%) required a nintedanib dose reduction, 4 (18.2%) temporary interruption, and 5 (22.7%) a permanent withdrawal. The absolute forced vital capacity (FVC) percentage after the first 12-month follow-up increased in 0.15 % (-3.8 – 5.5), which meant a relative increase in FVC of 2.3% (-4.7 – 7.9). <h3>Conclusion</h3> Nintedanib treatment for SSc-ILD showed a satisfactory safety profile, constituting diarrhea and elevated liver enzymes the most common adverse events related with the drug. An increase in infection rates cannot be established as the majority of the patients were under concomitant immunosuppressant therapies. FVC was stable during follow-up, which supports the effectiveness of nintedanib for SSc-ILD in real-life cohorts. <h3>References</h3> [1]<i>Perelas A, M Silver R, V Arrossi A, B Highland K. Systemic sclerosis-associated intersticial lung disease. The Lancet. 2020.</i> [2]<i>P Denton C, Khanna D. Systemic sclerosis. The Lancet. 2017.</i> [3]<i>Distler O, B Highland K, Gahlemann M, Azuma A, Fischer A, D. Mayes M et. al. Nintedanib for Systemic Sclerosis Associated Intersticial Lung Disease. The New England Journal of Medicine. 2019.</i> <h3>Acknowledgements:</h3> NIL. <h3>Disclosure of Interests</h3> Joseba Corada: None declared, Alfredo Guillen-Del-Castillo Speakers bureau: Received payment as speaker's bureau from Boehringer Ingelheim, Janssen and GSK., Paid instructor for: Received payment as speaker's bureau from Boehringer Ingelheim., Consultant of: Received consulting fees from Boehringer Ingelheim., Izar Blazquez: None declared, Claudia Codina: None declared, Adrian Antón: None declared, Jaume Mestre: None declared, Albert Gil: None declared, Janire Perurena-Prieto: None declared, Iñigo Ojanguren Consultant of: Consulting fees from Boehringer Ingelheim, Ana Villar Consultant of: Consulting fees from Boehringer Ingelheim, Carmen Pilar Simeon Aznar Speakers bureau: Received payment as speaker's bureau from Boehringer Ingelheim, Janssen and GSK., Paid instructor for: Received payment as speaker's bureau from Boehringer Ingelheim., Consultant of: Received consulting fees from Boehringer Ingelheim.